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The Iridex® Laser Console (532 model) are solid state lasers that are used to deliver laser energy in either continuous wave pulse (CW-pulse® mode, for ophthalmic applications (532 and 577 models) and for Ear, Nose, and Throat (Otolaryngology) applications (532 model only). Iridex® 532 Laser The Iridex® 532 Laser is indicated for use in soft and fibrous tissue, including osseous tissue incision, excision, coagulation, vaporization, ablation and vessel hemostasis in the medical specialties of, ear, nose and throat (ENT)/otolaryngology, and ophthalmology as follows: Ophthalmology Indicated for retinal photocoagulation, laser trabeculoplasty, iridoplasty including: - · Retinal photocoagulation (RPC) for the treatment of - o Diabetic retinopathy, including: - Nonproliferative retinopathy - Macular edema - Proliferative retinopathy - o Retinal tears and detachments - o Lattice degeneration - o Age-related macular degeneration (AMD) - o Retinopathy of prematurity - o Sub-retinal (choroidal) neovascularization - o Central and branch retinal vein occlusion - · Laser trabeculoplasty, iridotomy, iridoplasty for the treatment of glaucoma, including - o Primary open angle/Closed angle Ear, Nose, and Throat (ENT)/Otolaryngology Otosclerotic Hearing loss and/or diseases of the inner ear: - · Stapedectomy - · Stapedotomy - · Myringotomies - · Lysis of Adhesions - · Control of Bleeding - · Removal of Acoustic Neuromas - · Soft tissue Adhesion in Micro/Macro Otologic Procedures Iridex® 577 Laser The Iridex® 577 Laser is indicated for use in soft and fibrous tissue, including osseous tissue incision, excision, coagulation, vaporization, ablation and vessel hemostasis in the medical specialty of ophthalmology as follows: Ophthalmology Indicated for use in photocoagulation of both anterior and posterior segments including: - · Retinal photocoagulation, panretinal photocoagulation and intravitreal endophotocoagulation of vascular and structural abnormalities of the retina and choroid including: o Proliferative and nonproliferative diabetic retinopathy o Choroidal neovascularization o Branch retinal vein occlusion o Age-related macular degeneration (AMD) o Retinal tears and detachments o Retinopathy of prematurity · Iridotomy, iridectomy and trabeculoplasty in angle closure glaucoma and open angle glaucoma

The Iridex 532/577 Laser consoles are solid state lasers that are used to deliver laser energy in continuous wave and MicroPulse® for ophthalmic applications and (for 532 only) ear, nose, and throat (ENT) / otolaryngology applications. The Iridex® 532 Laser delivers a 532 nm wavelength (green) laser emission, and the Iridex® 577 Laser delivers a 577mm wavelength (true-yellow) laser emission. The Iridex 532 Laser and the Iridex 577 Laser systems are comprised of a laser console with footswitch and an optical fiber delivery device. Each laser console model contains two laser diodes as follows: - Iridex 532 Laser: 532 nm for Treatment and 650 nm for Aiming beam ● - Iridex 577 Laser: 577 nm for Treatment and 650 nm for Aiming beam ● imaging optics, power supply, control electronics, and software/embedded firmware (with microprocessor). Lasing can only be initiated from the footswitch. Optical fiber Delivery Devices are provided separately.

Intended for use in the treatment of ocular pathology in both the posterior and anterior segments. Intended for use in the posterior segment to perform retinal photocoagulation, panretinal photocoagulation, focal photocoagulation and grid photocoagulation for vascular and structural abnormalities of the retina and choroid including: (532nm) - proliferative and non-proliferative diabetic retinopathy - macular edema - choroidal neovascularization associated with wet age-related macular degeneration - age-related macular degeneration - lattice degeneration - retinal tears and detachments (577nm) - proliferative and non-proliferative diabetic retinopathy - macular edema - choroidal neovascularization associated with wet age-related macular degeneration - age-related macular degeneration - lattice degeneration - retinal tears and detachments Intended for use in the treatment of ocular pathology in the anterior segment including: (532 nm and 577nm) - iridotomy - trabeculoplasty

The Iridex PASCAL® (532 nm and 577 nm models) is an ophthalmic scanning laser system. PASCAL is an acronym for Pattern SCAn Laser. The system can perform single shot photocoagulation as is performed conventionally. In addition, the system is equipped with proprietary laser scanning technology that provides the user with the option to perform laser pattern scanning. This allows the user to place many laser treatment spots in a patient's eye rapidly by performing pattern scan laser photocoagulation. The system will scan user-selectable patterns of laser spots into a patient's eye. The system includes a table for housing the laser module and associated electronics. A slit lamp is also integrated in the table enabling the interface to be at the base of the slit lamp, i.e., no external cabling. The table is smaller in size compared to prior versions to accommodate use in smaller rooms. In addition to single shot and pattern scanning the system also supports the use of a Laser Indirect Ophthalmoscope (LIO) with optical fiber port for connection of a LIO. The system is available with either 532nm or 577nm laser emission.

The Iridex 810 Laser is indicated for retinal photocoagulation, laser trabeculoplasty, transscleral cyclophotocoagulation, transscleral retinal photocoagulation, and other diode laser treatments. The following are examples of applications for the Iridex 810 Laser. CONDITION: Diabetic Retinopathy (Nonproliferative Retinopathy, Macular Edema, Proliferative Retinopathy), Glaucoma (Primary Open Angle, Closed Angle, Refractory Glaucoma (recalcitrant/uncontrolled)), Retinal Tears, Detachments, and Holes, Lattice Degeneration, Age-Related Macular Degeneration (AMD), Intra-Ocular Tumors (Choroidal Hemangioma, Choroidal Melanoma, Retinoblastoma), Retinopathy of Prematurity, Sub-Retinal (choroidal) Neovascularization, Central and Branch Retinal Vein Occlusion TREATMENT: Panretinal Photocoagulation (PRP); Focal and Grid Laser Treatments, Laser Trabeculoplasty; Iridotomy; Transscleral Cyclophotocoagulation (TSCPC), Transscleral Retinal Photocoagulation (TSRPC); Focal and Grid Laser Treatments, Focal and Grid Laser Treatments, Focal and Grid Laser Treatments, Focal and Grid Laser Treatments, PRP; TSRPC; Focal and Grid Laser Treatments, Focal and Grid Laser Treatments, PRP; Focal and Grid Laser Treatments

The Iridex 810 Laser system is comprised of a laser console with footswitch and an optical fiber delivery device. The laser console contains two laser diodes (810 mm for Treatment and 650 nm for Aiming beam), imaging optics, power supply, control electronics, and software/embedded firmware (with microprocessor). Lasing can only be initiated from the footswitch. Optical fiber Delivery Devices are provided separately.

The Iridex 810 Laser is indicated for retinal photocoagulation, transscleral cyclophotocoagulation, transscleral retinal photocoagulation, and other diode laser treatments. The following are examples of applications for the Iridex 810 Laser. CONDITION: Diabetic Retinopathy (Nonproliferative Retinopathy, Macular Edema, Proliferative Retinopathy), Glaucoma (Primary Open Angle, Closed Angle, Refractory Glaucoma (recalcitrant/uncontrolled)), Retinal Tears, Detachments, and Holes, Lattice Degeneration, Age-Related Macular Degeneration (AMD), Intra-Ocular Tumors (Choroidal Hemangioma, Choroidal Melanoma, Retinoblastoma), Retinopathy of Prematurity, Sub-Retinal (choroidal) Neovascularization, Central and Branch Retinal Vein Occlusion. TREATMENT: Panretinal Photocoagulation (PRP); Focal and Grid Laser Treatments, Laser Trabeculoplasty; Iridotomy; Transscleral Cyclophotocoagulation (TSCPC), Transscleral Retinal Photocoagulation (TSRPC); Focal and Grid Laser Treatments, PRP; Focal and Grid Laser Treatments, Focal and Grid Laser Treatments, Focal and Grid Laser Treatments, PRP; TSRPC; Focal and Grid Laser Treatments, Focal and Grid Laser Treatments, PRP; Focal and Grid Laser Treatments.

The Iridex 810 Laser system is comprised of a laser console with footswitch and an optical fiber delivery device. The laser console contains two laser diodes (810 nm for Treatment and 650 nm for Aiming beam), imaging optics, power supply, control electronics, and software/embedded firmware (with microprocessor). Lasing can only be initiated from the footswitch. Optical fiber Delivery Devices are provided separately.

The Iridex TruFocus LIO Premiere Laser Indirect Ophthalmoscope with the Family of Iridex® IQ Laser Systems (IQ 532 [532nm], IQ 577 [577mm], IQ 630-670 [630mm-670mm], IQ 810 [810nm]), hand pieces & accessories that are used with them to deliver laser energy in either CW-pulse™ or LongPulse™ mode. Intended for soft and fibrous tissue, including osseous tissue incision, coagulation, vaporization, ablation and vessel hemostasis in the medical specialties of, dermatology, ear, nose and throat (ENT)/ otolaryngology, and ophthalmology as follows: 532 nm: - Dermatology: - · Pigmented Skin Lesions - · Vascular Lesions Ear, Nose, and Throat (ENT)/ Otolaryngology Otosclerotic Hearing loss and/or diseases of the inner ear: - · Stapedectomy - · Stapedotomy - · Myringotomies - · Lysis of Adhesions - · Control of Bleeding - · Removal of Acoustic Neuromas - · Soft tissue Adhesion in Micro/Macro Otologic Procedures Ophthalmology: Indicated for retinal photocoagulation, laser trabeculoplasty, iridoplasty including: - · Retinal photocoagulation (RPC) for the treatment of - Diabetic retinopathy, including: - Nonproliferative retinopathy - Macular edema - Proliferative retinopathy - · Retinal tears and detachments - Lattice degeneration - Age-related macular degeneration (AMD) - Retinopathy of prematurity - Sub-retinal (choroidal) neovascularization - Central and branch retinal vein occlusion - · Laser trabeculoplasty, iridotomy, iridoplasty for the treatment of glaucoma, including - Primary open angle/Closed angle 577nm Dermatology: - · Treatment of Vascular and pigmented lesions Ophthalmology: Indicated for use in photocoagulation of both anterior and posterior segments including: · Retinal photocoagulation, panretinal photocoagulation and intravitreal endophotocoagulation of vascular and structural abnormalities of the retina and choroid including : - Proliferative and nonproliferative diabetic retinopathy; - Choroidal neovascularization; - Branch retinal vein occlusion; - Age-related macular degeneration - Retinal tears and detachments - Retinopathy of prematurity - · Iridotomy, iridectomy and trabeculoplasty in angle closure glaucoma and open angle glaucoma 630 - 670nm Ophthalmology: - Indicated for use in photocoagulation of both anterior and posterior segments including: · Retinal photocoagulation, panretinal photocoagulation and intravitreal endophotocoagulation of vascular and structural abnormalities of the retina and choroid including: - Proliferative and non-proliferative diabetic retinopathy; - Choroidal neovascularization: - Branch retinal vein occlusion; - Age-related macular degeneration - Retinal tears and detachments - Retinopathy of prematurity - · Iridotomy, iridectomy and trabeculoplasty in angle glaucoma and open angle glaucoma 810nm Ophthalmology: Indicated for retinal photocoagulation, laser trabeculoplasty, transscleral cyclophotocoagulation, transscleral retinal photocoagulation, iridotomy, including the following examples: - · Retinal photocoagulation for the treatment of: - · Diabetic retinopathy, including: - Nonproliferative retinopathy - Macular edema - Proliferative retinopathy - · Retinal Tears, Detachments and Holes - · Lattice degeneration - · Age-related macular degeneration (AMD) with choroidal neovascularization (CNV) - · Retinopathy of prematurity - · Sub-retinal (choroidal) neovascularization - · Central and Branch Retinal Vein Occlusion - · Laser trabeculoplasty, Iridotomy, Transscleral Cyclophotocoagulation (TSCPC) for the treatment of glaucoma, including: - Primary open angle - Closed angle - Refractory Glaucoma (recalcitrant/uncontrolled)

The Iridex TruFocus LIO Premiere Laser Indirect Ophthalmoscope is a light combination and reflection viewing system used with the Iridex IQ/GL/SL/TX laser system families. The LIO combines a laser treatment beam from an Iridex laser source with the illumination beam of a Heine binocular indirect ophthalmoscope into a mixed optical beam used by a physician with a handheld ophthalmic examination (condensing) lens to enter a patient's pupil and to collect and view reflections by a patient's retina returned through the same pupil. It provides a portable alternative to patients who cannot be examined or treated with a fixed slit lamp adapter. The LIO is supplied non-sterile and is intended for reuse and worn on the physician's head to view and treat the patient's retina. The device can be used to evaluate and treat patients of all ages, including infants, in an office, operating room and ambulatory surgical center setting.

The Iridex TruFocus LIO Premiere Laser Indirect Ophthalmoscope with the Family of Iridex® IQ Laser Systems (IQ 532 [532nm], IQ 577 [577nm], IQ 630-670 [630nm-670nm], IQ 810 [810nm]), hand pieces & accessories that are used with them to deliver laser energy in either CW-pulse, M or LongPulse TM mode. Intended for soft and fibrous tissue, including osseous tissue incision, coagulation, vaporization, ablation and vessel hemostasis in the medical specialties of, dermatology, ear, nose and throat (ENT)/ otolaryngology, and ophthalmology as follows: 532 nm: Dermatology: - · Pigmented Skin Lesions - · Vascular Lesions Ear, Nose, and Throat (ENT)/ Otolaryngology Otosclerotic Hearing loss and/or diseases of the inner ear: - · Stapedectomy - · Stapedotomy - · Myringotomies - · Lysis of Adhesions - · Control of Bleeding - · Removal of Acoustic Neuromas - · Soft tissue Adhesion in Micro/Macro Otologic Procedures Ophthalmology: Indicated for retinal photocoagulation, laser trabeculoplasty, iridotomy, iridoplasty including: - · Retinal photocoagulation (RPC) for the treatment of - Diabetic retinopathy, including: - Nonproliferative retinopathy - Macular edema - Proliferative retinopathy - · Retinal tears and detachments - Lattice degeneration - Age-related macular degeneration (AMD) - Retinopathy of prematurity - Sub-retinal (choroidal) neovascularization - Central and branch retinal vein occlusion - · Laser trabeculoplasty, iridotomy, iridoplasty for the treatment of glaucoma, including - Primary open angle/Closed angle 577nm Dermatology: - · Treatment of Vascular and pigmented lesions Ophthalmology: Indicated for use in photocoagulation of both anterior and posterior segments including: · Retinal photocoagulation, panretinal photocoagulation and intravitreal endophotocoagulation of vascular and structural abnormalities of the retina and choroid including : - Proliferative and nonproliferative diabetic retinopathy; - Choroidal neovascularization; - Branch retinal vein occlusion; - Age-related macular degeneration - Retinal tears and detachments - Retinopathy of prematurity - · Iridotomy, iridectomy and trabeculoplasty in angle closure glaucoma and open angle glaucoma 630 - 670nm Ophthalmology: Indicated for use in photocoagulation of both anterior and posterior segments including: · Retinal photocoagulation, panretinal photocoagulation and intravitreal endophotocoagulation of vascular and structural abnormalities of the retina and choroid including: - Proliferative and non-proliferative diabetic retinopathy; - Choroidal neovascularization: - Branch retinal vein occlusion; - Age-related macular degeneration - Retinal tears and detachments - Retinopathy of prematurity - · Iridotomy, iridectomy and trabeculoplasty in angle glaucoma and open angle glaucoma 810nm Ophthalmology: Indicated for retinal photocoagulation, laser trabeculoplasty, transscleral cyclophotocoagulation, transscleral retinal photocoagulation, iridotomy, including the following examples: - Retinal photocoagulation for the treatment of: - Diabetic retinopathy, including: - Nonproliferative retinopathy Macular edema Proliferative retinopathy - Retinal Tears, Detachments and Holes - Lattice degeneration - Age-related macular degeneration (AMD) with choroidal neovascularization (CNV) - Retinopathy of prematurity - Sub-retinal (choroidal) neovascularization - Central and Branch Retinal Vein Occlusion - Laser trabeculoplasty, Iridotomy, Transscleral Cyclophotocoagulation (TSCPC) for the treatment of glaucoma, including: - Primary open angle - Closed angle - Refractory Glaucoma (recalcitrant/uncontrolled)

Iridex TruFocus LIO Premiere with the Family of Iridex® IQ Laser Systems (IQ 532 [532nm], IQ 577 [577nm], IQ 630-670 [630mm-670mm], and IQ 810 [810mm]), hand pieces, delivery devices & accessories is a delivery accessory used with the Iridex family of IQ laser systems (IQ532, IQ577, and IQ810). Iridex TruFocus LIO Premiere and the Family of Iridex® IO Laser Systems (10 532 1532nm), 10 577 [577mm], IQ 630-670 [630nm-670mm], IQ 810 [810nm]), hand pieces, delivery devices & accessories is a headmounted diagnostic indirect ophthalmoscope which is used with a handheld lens to view and perform laser treatments on a patient's retina. It allows binocular visualization of the peripheral retina not easily viewed at the slit lamp and can be used to evaluate and treat patients, including infants, while they are in a supine position. The LIO is a laser delivery device used to perform transpupillary laser photocoagulation during noninvasive ocular surgical procedures. The LIO is supplied non-sterile and is intended for reuse. Variants of the device may relate to the style of headband, laser wavelength to be delivered, and the device to laser connector (i.e. RFID).

The Family of IRIDEX® IQ Laser Systems (IQ 532 [532nm], IQ 630-670 [630nm-670mm], IQ 810 [810mm] [IRIDEX Cyclo G6 Laser System]) and the hand pieces & accessories that are used with them to deliver laser energy in either CW-pulse, MicroPulse™ mode. Intended for soft and fibrous tissue, including osseous tissue incision, excision, coagulation, vaporization, ablation and vessel hemostasis in the medical specialties of, dermatology, ear, nose and throat (ENT)/ otolaryngology, and ophthalmology as follows: 810nm (The IRIDEX Cyclo G6 Laser System) Ophthalmology: The IRIDEX® Cyclo G6™ Laser System and Probe Delivery Devices (G-Probe Illuminate, & MicroPulse® P3) are used to deliver laser energy in either CW-Pulse (CW) or MicroPulse (uP) treatment mode and indicated for the treatment of Glaucoma: MicroPulse P3 Device: For the treatment of Glaucoma including: • Primary Open-Angle • Closed-Angle • Refractory. Treatment (Intended Use): Transscleral Cyclophotocoagulation (TSCPC) of the ciliary processes. Mode: μP G-Probe & G-Probe Illuminate: For the treatment of Glaucoma including: • Primary Open-Angle • Closed-Angle • Refractory. Treatment (Intended Use): Transscleral cyclophotocoagulation (TSCPC) of the ciliary processes. Mode: CW

The Iridex Cyclo G6 is an 810nm (diode) ophthalmic laser comprised of the following main components: - Main console containing the major electrical components, including: - Control Panel including control knobs (power, interval, duration or software assigned function), treat/standby button, and display; - Two delivery device fiber-optic connector ports (only one active at a time); - LIO illumination connection; - Smart key port for detecting/operating safety filters and/or accessory identification; - Emergency stop switch; - Key switch; - Connector ports for the footswitch, remote control, and power cord; - A treatment Footswitch (either wired, wireless, or wireless with PowerAdjust); - A Wired Remote Control that duplicates the control panel; - Delivery Accessories including G-Probe and MicroPulse P3 probe Handpieces, and the G-Probe Illuminate - Optional Cart/Stand The laser system automatically enters the "Standby" mode after it is turned on and completes its internal "selftest". Laser emission is not possible until the user attaches the proper delivery device, selects the desired treatment settings, verifies eye safety filter status, places the system into "Ready", and depresses the footswitch. The system has a primary display screen (power, interval, duration, pulse mode, aiming beam brightness, illumination brightness, treatment/standby toggle, counter reset) and additional screens for ancillary options (system volume, display contrast/brightness, preset selection (user defined/generated), aiming beam settings). The user may adjust power, treatment duration, treatment interval, type of laser output mode (CW-pulse, MicroPulse), aiming beam brightness, illumination brightness, and reset the laser shot counter. Additionally, for some delivery devices the user may optionally select the on/off operation of the countdown timer on the display screen as well as the on/off function of the voice countdown. The G-Probe Illuminate that is the subject of this 510(k) is a handheld fiber optic delivery device. It is intended to be used to perform transscleral cyclophotocoagulation of the ciliary processes. It is differentiated from the G-Probe described in earlier submissions by the incorporation of two additional optical fibers to provide white light transillumination of the optic globe. Such transillumination can aid probe placement by revealing the location of internal ocular structures such as the ciliary processes. The incorporation of this transillumination function into a multifunction probe offers the user similar functionality as a separate handheld transilluminator, with a more convenient setup that requires fewer hands or assistants to operate. It is provided as a sterile, single-use device.

The Family of IR.IDEX® IQ Laser Systems (IQ 532 [532nm], IQ 630-670 [630mm-670m], IQ 810 [810nm] [IRIDEX Cyclo G6 Laser System]) and the hand pieces & accessories that are used with them to deliver laser energy in either CW-pulse, MicroPulse TM or LongPulse TM mode. Intended for soft and fibrous tissue, including osseous tissue incision, excision, coagulation, vaporization, ablation and vessel hemostasis in the medical specialties of, dematology, ear, nose and throat (ENT)/ otolaryngology, and ophthalmology as follows: 810nm (IRIDEX Cyclo G6 Laser System) Ophthalmology: The IRIDEX® Cyclo G6 Laser System and Probe Delivery Devices (G-Probe & MicroPulse P3) are used to deliver laser energy in either CW-Pulse (CW) or MicroPulse™ (uP) treatment mode and indicated for the treatment of Glaucoma: MicroPulse P3 Device: For the treatment of Glaucoma including: • Primary Open-Angle • Closed-Angle • Refractory. Treatment: Transscleral cyclophotocoagulation (TSCPC) of the ciliary processes. Mode: uP G-Probe: For the treatment of Glaucoma including: • Primary Open-Angle • Closed-Angle • Refractory. Treatment: Transscleral cyclophotocoagulation (TSCPC) of the ciliary processes. Mode: CW

The Iridex Cyclo G6 is comprised of the following main components: - Main console containing the major electrical components, including: - Control Panel including control knobs (power, interval, duration or software assigned function), treat/standby button, and display; - Two delivery device fiber-optic connector ports (only one active at a time); - LIO illumination connection; - Smart key port for detecting/operating safety filters and/or accessory identification: - Emergency stop switch: - Key switch; - Connector ports for the footswitch, remote control, and power cord; - A treatment Footswitch (either wired, wireless, or wireless with PowerAdjust); - A Wired Remote Control that duplicates the control panel; - Delivery Accessories including G-Probeand MicroPulse P3 probe Handpieces. Microscope Adapters, and Laser Indirect Ophthalmoscopes (these are not used with the Cyclo G6 but are available for use with the other members of the laser family). - Optional Cart/Stand

The VariLite Laser System is intended for use in dermatological applications: The 532 nm wavelength delivered with VariLite handpieces, DioLite 532 handpieces, and the ScanLite Scanner is indicated for: - the treatment of vascular lesions including: - Telangiectasia - Cherry Angiomas - Leg Veins - Neovascularization - Spider Angiomas - Port Wine Stains - Roscea - Venous Lakes - the treatment of benign pigmented lesions including: - Lentigines - Freckles - Dermatosis Papulosis Nigra - Poikloderma of Civatte - Café- au- lait Stains - Melasma - the treatment of cutaneous lesions including: - Verruca - Keratoses - Skin Tags - the treatment of moderate inflammatory acne vulgaris. The 940 nm wavelength delivered with VariLite handpieces is indicated for: - the treatment of vascular lesions including: - Telangiectasia - Cherry Angiomas - Leg Veins - Neovascularization - Spider Angiomas - Port Wine Stains - Roscea - Venous Lakes - the treatment of benign pigmented lesions including: - Lentigines - Freckles - Dermatosis Papulosis Nigra - Poikloderma of Civatte - Café- au- lait Stains - Melasma - hair removal.

The VariLite is a dual wavelength medical diode laser source that delivers laser light at either 532 nm or 940 nm. Its main components are a laser console, footswitch, and a variety of fiber optic handpiece delivery devices, including manual handpieces and the ScanLite Scanner, which are all considered part of the VariLite Laser System. The VariLite console is also intended to be compatible with other delivery devices that have been the subject of previous 510(k) applications. These devices include DioLite 532 handpieces (K964074).